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Ima Miermeister

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RE: Potential QMS audit under MDR

Posted By Ima Miermeister 28-Nov-2019 00:52
Found In Egroup: Regulatory Open Forum \ view thread
Or the ISO 13485 will be certified in a separate certificate (as it is currently the practice for EC certs with one EC cert for the company, individual ones for the products or product families and other ones for ISO 13485 and MDSAP, etc.)? When searching the certificate database of TüV Süd, there ...

RE: Potential QMS audit under MDR

Posted By Ima Miermeister 28-Nov-2019 00:51
Found In Library: Regulatory Open Forum

RE: Potential QMS audit under MDR

Posted By Ima Miermeister 26-Nov-2019 23:40
Found In Egroup: Regulatory Open Forum \ view thread
Just to add to the point on MDR certificates, in case it's still of interest - Mindray is posting their certificate from TüV Süd on its website, CND code is found on the 2nd page of the certificate.(https://www.mindray.com/en/news/details/Mindray_becomes_the_first_China_medical_device_manufacturer_t ...